News & Events: Announcements

02/04/16 - Notice of Change in Final Product Shelf Life

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We would like to take this opportunity to inform our valued partners of a recent change that increases the shelf life of cryopreserved amniotic membrane and umbilical cord products (i.e. AmnioGraft®, AmnioGuard®, PROKERA®, NEOX® 100, NEOX® lK, CLARIX® 100, and CLARIX® 1K) manufactured by TissueTech, Inc. and distributed by Bio-Tissue, Inc. or Amniox Medical Inc.This change is based on a thorough review of validation studies, histological attributes, and packaging integrity and has been documented, evaluated and approved by relevant and responsible parties within our organization.

Previous Shelf Life
The previous shelf life of our product was 2 years in a -80 ° C (- 112 °F) ultra-low temperature freezer, 1 year in a -20° C (-4 ° F) standard freezer and 3 months in a 4 °C (39° F) standard refrigerator.

The final product label had a 2 year expiration date with "(at -80° C)" stated. The Product Insert provided with each unit documented the acceptable storage parameters as mentioned above.

What is the Change?
Beginning February 2016, the new shelflife will be extended to 2 years with a temperature range of -80°C to +4 °C (-112°F to 39 °F) (ultra-low temperature freezer to standard refrigerator). Product labels will now reflect these changes.

  • The storage parameter will be indicated as "(-80°C to 4 °C)" below the 2 year expiration date.
  • Although synonymous as it relates to source donor tissue, "DONOR ID" will replace the word "LOT".

Additionally, products exposed to controlled room temperature of 20°c - 25 ° c (68 ° F - 77 ° F) for up to 6 hours may be returned to cold temperature storage as long as the packaging remains unopened and intact. Product inserts will reflect this.

You will begin seeing these labeling changes in the next few months on our products once existing inventories have been depleted.

During this "transition phase", you may encounter the "old" storage temperature parameters on the final product label and the "new" temperature parameter on the packaging labels. TissueTech does not consider this information to be conflicting and therefore acceptable; all other information between the labels matches and assures proper trace-ability.

For those units existing in a customer's, consignee's or distributor's inventory, TissueTech is applying the same logic; therefore, all existing inventory stored from -80°C to 4°C may now use the 2 year expiration date on the final product label.

Please use this notification to assess the impact on your own organization and, if necessary, properly plan for this change. Please contact your Sales Representative or your Customer Service Representative for any additional questions. Thank you for your continued business.